To: tuck who wrote (3123) | 4/23/2018 5:03:16 PM | From: tuck | | | Now the FDA AdCom vote. Two doses. 10-5 in favor of 2mg, and 10-5 against the 4mg on the risk-benefit metric. If approved, can the 2 mg dose make commercial inroads on competing products from PFE and ABBV?
Cheers, Tuck |
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To: scaram(o)uche who wrote (3175) | 4/24/2018 11:56:50 AM | From: Miljenko Zuanic | | | Not clear is it JAK2 related, not related to platelets count (which actually decrease, not increase), so search for an answer not condemn drug in start. No trial can be executed to CONFIRM safety signal (not ETHICAL). So, THE ONLY WAY is REAL LIFE EXPERIENCE (controlled with BOX warning and proper management). Hope NEW FDA will be more open for suggestions!!??
Approval without option to increase dose, IF needed, is worthless. Some panel members had open mind, but they were in minority. |
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